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Trial record 10 of 266 for:    Pancreatic Cancer AND Resectable

Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.

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ClinicalTrials.gov Identifier: NCT02506803
Recruitment Status : Unknown
Verified May 2016 by Hiroki Yamaue, Wakayama Medical University.
Recruitment status was:  Recruiting
First Posted : July 23, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University

Brief Summary:
Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: NAC-GEMABR Phase 1

Detailed Description:
Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GEMABR is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel for Patients With Borderline Resectable Pancreatic Cancer.
Study Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: NAC-GEMABR
Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.
Drug: NAC-GEMABR
NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.
Other Name: Gemcitabine, nab-paclitaxel




Primary Outcome Measures :
  1. Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks. ]
    Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.


Secondary Outcome Measures :
  1. The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 24 weeks ]
  2. The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer. [ Time Frame: Up to 30 weeks ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically proven invasive pancreatic ductal carcinoma
  • Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)

    1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma
    2. Patients indicated distal pancreatectomy with en bloc celiac axis resection
  • PS (ECOG) 0-1
  • ≧20 years old and < 80 years old
  • First line treatment
  • The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin <2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL
  • Written informed consent to participate in this study

Exclusion Criteria:

  • Severe drug hypersensitivity
  • Multiple primary cancers within 5 years
  • Severe infection
  • With grade2 or more severe peripheral neuropathy
  • With intestinal paralysys, ileus
  • Interstitial pneumonia or pulmonary
  • With uncontrollable pleural effusion or ascites
  • Receiving atazanavir sulfate
  • With uncontrollable diabetes
  • With uncontrollable heart failure, angina, hypertension, arrhythmia
  • With severe psychological symptoms
  • With watery diarrhea
  • Pregnant or lactating women, or women with known or suspected pregnancy
  • Inappropriate patients for entry on this study in the judgment of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506803


Contacts
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Contact: Hiroki Yamaue, M.D., PhD +81-73-441-0613 ext 5112 yamaue-h@wakayama-med.ac.jp

Locations
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Japan
Wakayama Medical University Recruiting
Wakayama, Japan, 641-8510
Principal Investigator: Hiroki Yamaue, M.D., PhD         
Sub-Investigator: Ken-ichi Okada, M.D., PhD         
Sub-Investigator: Manabu Kawai, M.D., PhD         
Sub-Investigator: Seiko Hirono, M.D., PhD         
Sub-Investigator: Motoki Miyazawa, M.D., PhD         
Sub-Investigator: Atsushi Shimizu, M.D., PhD         
Sub-Investigator: Yuji Kitahata, M.D., PhD         
Sponsors and Collaborators
Wakayama Medical University
Investigators
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Principal Investigator: Hiroki Yamaue, M.D., PhD Wakayama Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hiroki Yamaue, Dean & Professor of the second department of surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT02506803     History of Changes
Other Study ID Numbers: NAC-GEMABR
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs